Miltefosine (By mouth)

Miltefosine (mil-te-FOS-een)

Treats leishmaniasis.

Brand Name(s):

Impavido

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

This medicine is not right for everyone. Do not use it if you had an allergic reaction to miltefosine, if you have SjÖgren-Larsson syndrome, or if you are pregnant.

How to Use This Medicine:

Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk.
• Swallow the capsule whole. Do not crush, break, dissolve, or chew it.
• Take all of the medicine in your prescription to clear up your infection, even if you feel better after the first few doses.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before taking this medicine. Use an effective form of birth control to prevent pregnancy during treatment and for 5 months after your last dose.
• Do not breastfeed during treatment and for 5 months after the last dose.
• Tell your doctor if you have kidney disease, liver disease, or eye or vision problems.
• This medicine may cause the following problems:
  • Liver problems
  • Stomach or bowel problems
  • Serious skin reaction, including Steven-Johnson syndrome
  • Eye or vision problems
• Diarrhea and vomiting may occur while taking this medicine. These side effects may prevent birth control pills from working properly. You may use other forms of birth control (including condoms, diaphragms, or contraceptive foams or jellies).
• This medicine lowers the number of certain blood cells, so you may bleed or bruise more easily. Be careful to avoid injuries.
• This medicine may decrease sperm count, semen quality, or semen volume (amount of fluid released upon ejaculation) in some males and may also cause abnormal changes in menstrual cycles in females. This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Blurred vision, eye pain, irritation, or tenderness, sensitivity to light
• Change in how much or how often you urinate
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Diarrhea
• Fever
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Headache, dizziness, sleepiness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 5/4/2025